|- candidate number||8642|
|- NTR Number||NTR2597|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-nov-2010|
|- Secondary IDs||171102007 / NL32073.068.10; ZonMw / METC MUMC|
|- Public Title||Individually tailored elastic compression therapy after deep venous thrombosis (DVT).|
|- Scientific Title||Individually tailored elastic compression therapy after deep venous thrombosis in relation to the incidence of post thrombotic .syndrome. A multi-center, randomized, allocation concealed, single blinded clinical trial in patients with acute proximal DVT with a follow-up of 24 months.|
|- ACRONYM||Acronym: The Ideal DVT study (Individualized duration of elastic compression therapy against long-term duration of therapy).|
|- hypothesis||Tailoring elastic compression therapy to individual patients needs will not lead to an increased incidence of the post thrombotic syndrome, substantial costs will be saved and the quality of life of individual patients will improve. |
|- Healt Condition(s) or Problem(s) studied||Deep vein thrombosis , Elastic stockings , Postthrombotic syndrome|
|- Inclusion criteria||1. Legal age (18 yrs);|
2. Informed consent;
3. Acute objectively documented DVT of the leg;
4. Adequate anticoagulation.
|- Exclusion criteria||1. Previous DVT in the affected leg;|
2. Recurrent DVT in the first 6 months following inclusion;
3. Preexistent venous insufficiency ( skin signs C4-C6 on CEAP score or requiring ECS therapy);
4. Contraindication for elastic compression therapy ( arterial insufficiency);
5. Active thrombolysis;
6. Life expectancy < 6 months.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mrt-2011|
|- planned closingdate||15-mrt-2016|
|- Target number of participants||864|
|- Interventions||Elastic compression therapy with a standard duration of 24 months compared to individually tailored duration of elastic compression therapy, following an initial therapeutic period of 6 months, based on signs and symptoms according to the Villalta scale. |
|- Primary outcome||The occurrence of PTS at 24 months after the event of acute DVT (the observers will be blinded to the allocated treatment arm). |
|- Secondary outcome||1. Health Related Quality of Life (HRQOL), will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated (time point baseline, 3, 6, 12 and 24 months);|
2. Recurrent venous thrombosis (time point 24 months);
3. Mortality due to venous thrombosis (time point 24 months);
4. Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires (time point 3, 6, 12, 24 months);
5. Patient Preference will be elicited by conducting a discrete choice experiment (DCE) at time point 12 months.
|- Timepoints||1. Percentage PTS at 24 months (assessments performed at 3, 6, 12 and 24 months);|
2. Data on HRQOL at baseline, 3, 6, 12 en 24 months;
3. Patient preference at 12 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. MpH. A.J. Cate-Hoek, ten|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. MpH. A.J. Cate-Hoek, ten|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||pilot data; J Vasc Surg. 2010 Jul;52(1):132-8).
|- Brief summary||Rationale: |
In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and the quality of life for individual patients can be expected to improve.
To assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs.
A multi-center, randomized, allocation concealed, single-blinded clinical trial in patients with acute proximal DVT with a follow-up of 24 months.
Consecutive, adult outpatients after acute proximal DVT who present themselves at one of the participating centers.
ECS therapy with a standard duration of 24 months versus tailored ECS therapy following an initial therapeutic period of 6 months, based on signs and symptoms according to a Villalta scale.
Main study parameters/endpoints:
Primary outcome: Percentage of patients with PTS at two year follow-up.
Secondary outcomes: 1. Health Related Quality of Life (HRQOL), 2. Recurrent venous thrombosis,3. Mortality due to venous thrombosis, 4. Costs and 5. Patient preference.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The study burden for patients is kept to a minimum and will comprise of regular visits and questionnaires. The study burden for clinicians is low. Patients will be seen at regular intervals (3, 6, 12 and 24 months) at the outpatient clinic. Patients will receive questionnaires preceding their visits. A clinical score to assess post thrombotic complaints will be performed at the out clinic visits. Based on our previous findings we expect that due to individual tailoring of therapy, 50% of patients will need ECS therapy for a period of maximum 12 months, instead of 24 months. HRQOL may be positively affected. Shorter therapy duration is not anticipated to have a negative implication on the incidence of PTS during the 24 months period of follow-up (pilot data; J Vasc Surg. 2010 Jul;52(1):132-8).
|- Main changes (audit trail)|
|- RECORD||9-nov-2010 - 20-nov-2010|